Punes Serum Institute, which created MenAfric-Vac will apply for license to Drug Controller General of India (DCGI) shortly, to make the one-shot vaccine available in India.
The phase-III human trials of the vaccine on 823 people (5-10 years) -- reports of which are being put together for submission to DCGI -- found over 90% protection profile.
Serum Institute's Dr Prasad Kulkarni, who conducted the vaccine trials, told ToI from Pune that the meningococcus bacteria has about five serotypes A,B,C,Y and W. The serotype A meningococcus bacteria accounts for an estimated 80% of all cases in the meningitis belt -- with epidemics occurring at intervals of 7-14 years.
"This same type of bacteria -- serotype A -- causes outbreaks in India. The vaccine being used in Africa is perfect for India. We will apply for marketing license to the DCGI soon. We have conducted three trials of this vaccine in India. Phase-I was done on 74 healthy adults, PhaseII on 600 and Phase III on 823. The protection rate is always above 90% with minor sideeffects like injection site pain," Dr Kulkarni said.
He added, "Till date, India never had a conjugate vaccine. It only used meningococcal polysaccharide vaccines during large outbreaks to arrest the spread. However, the problem with non-conjugate vaccines are that it does not result in herd immunity, does not protect children below two years and its effects is not long lasting."
In the last year's epidemic, 14 African countries, implementing enhanced surveillance, had reported 88,199 cases of meningitis, including 5,352 deaths -- the highest since a 1996 outbreak.
Serum Institute, which took more than 10 years to develop the vaccine, is being used in 25 African nations -- from Ethiopia to Senegal -- that fall under the region's infamous meningitis belt. The vaccine costs less than 50 cents.
"We believe it will protect those vaccinated for two decades, and also cause herd immunity. This means it will provide long-term protection, and induce immunity in certain non-vaccinated persons, who live in proximity of those who are immunised, leading to broad community protection," Dr Kulkarni added. The countrywide vaccination of the population in the 1-29 age group kicked offin Burkina Faso on Monday.
Interestingly, MenAfriVac costs less than one-tenth of $500 million usually required to develop and launch a new vaccine in the market.
For more than 100 years, sub-Saharan Africa has suffered from meningitis epidemics. As many as 450 million are at risk from the disease across Africa. Typically, critical patients die within 24 to 48 hours of the onset of symptoms, and among the survivors around 10%-20% suffer brain damage, hearing loss or learning disability.
Developed by the Meningitis Vaccine Project (MVP) -- a partnership between the World Health Organization (WHO) -- and PATH, an INGO, with support from the Bill & Melinda Gates Foundation -- the new meningococcal A conjugate vaccine MenAfriVac has several advantages over the ones being used to combat meningitis epidemics in Africa. It protects one-year-old babies. It is expected to both protect from the disease for significantly longer than the vaccine being used to combat epidemics, and to reduce infection and transmission. Reduced transmission, in turn, protects the larger community, including family members and others, who have not been immunised.
Approximately 300 million will be targeted for mass vaccination across the meningitis belt, with the entire population (an estimated 450 million) then protected through the broader community protection that could reduce transmission of the disease.
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